The FDA says ads for drugs to suppress HIV are making false promises, and could be contributing to an epidemic of unsafe sex.
On bus shelters, billboards, subway stations and other public spaces in New York, San Francisco, Los Angeles and Miami, a relatively new addition to the landscape has come under fire. Critics are in an uproar over upbeat advertisements for prescription drugs designed to suppress the HIV virus. The ads often feature attractive, healthy looking models, with muscled bodies and chiseled faces that mirror the ideals of beauty often held up in gay enclaves from San Francisco to New York.
While it’s true that more and more HIV-positive people are responding to treatment with these anti-retroviral drugs, the Food and Drug Administration says the direct-to-consumer ads have crossed the line and are misleading the public about the realities of the disease. On April 27, the FDA ordered pharmaceutical companies to change the ads within 90 days.
In a strongly worded letter, FDA marketing division chief Thomas Abrams ordered pharmaceutical companies to create ads that are more “representative” of the realities of HIV, specifically citing lifestyle ads that feature “robust individuals engaged in strenuous activity” and “healthy-looking individuals.” The agency stated: “We are hereby informing application holders that may be promoting their HIV drugs to consumers without prominently displaying the limitations … or using images not generally representative of patients with HIV infection that such promotion is a violation of the Federal Food, Drug and Cosmetic Act.” The decision followed an intense campaign by AIDS activists in San Francisco, who were calling for a ban on the ads by both the FDA and the city.
Among the most widely criticized ads are those for the drugs Crixivan and Combivir. The ad for Crixivan features three athletic men and one woman who have just scaled a dramatic mountain peak, an athletic feat that many perfectly healthy people probably couldn’t do. Meanwhile, the ad for Combivir shows a muscular and attractive African-American with a towel over his shoulder, hinting that he has just completed a rugged workout. The text tells us he’s “living proof” of the power of Combivir.
Advances in treatment have led to a lot of good news for those infected with the HIV virus, which causes AIDS. But new problems are emerging too. Doctors and public health analysts say there is growing apathy toward preventing the disease. And this, they believe, is contributing to the current upsurge in HIV infection rates.
In San Francisco the rate of annual HIV infection has doubled since 1997, rising from 1.04 percent to 2.2 percent of the city’s estimated 34,000 uninfected gay and bisexual men. And that increase has disproportionately affected young gay men. A recent preliminary study by the city’s Public Health Department found that 62 percent of the heterosexual and gay male respondents stated that they believe HIV drug advertising leads to unsafe sex. But critics point out that the study asks respondents whether they believe the ads affect a person’s decision to have unprotected sex, and not whether the ads actually affected the respondent’s decision to engage in unsafe sex. In other words, it didn’t establish a direct link between the ads and HIV infection; but it still provided ammunition for AIDS activists.
The controversy over advertising for HIV drugs comes at a time when there is increasing FDA scrutiny of direct-to-consumer advertising of prescription drugs. There has been an enormous increase in those ads since the FDA loosened its regulations in 1997. According to healthcare consulting group IMS Health, the pharmaceutical industry spends more than $2.6 billion on direct-to-consumer ads each year in the U.S. In some of the more recognizable examples, Bob Dole has served as a spokesman for Pfizer’s erectile dysfunction drug Viagra. And ads for antihistamines like Allegra and Claritin show ethereal pictures of allergy sufferers blissfully romping through pollen-filled meadows — a scene that might otherwise lead to an emergency room visit.
Unlike the ads for Viagra and Claritin, which pitch two very real prospects — septuagenarian erections or a roll in the hay without fear of hay fever — the HIV drug ads depict a lifestyle that is highly improbable for the vast majority undergoing HIV treatment. They fail to spell out the potentially deadly kidney and liver problems, diarrhea, nausea and other side effects that are endemic to anti-retroviral treatments. But others believe the ads portray the disease in a more mainstream and positive light.
Andrew Sullivan, a conservative writer who is HIV-positive, recently ranted about the FDA’s decision to make drug companies change the images in their ads on his Web site. “I can see the point of having small-print in the ads explaining side-effects (as the ads now include by law) but what on earth is gained by re-stigmatizing the sick and undermining the self-esteem of people with HIV?” Sullivan wrote in a column. “Don’t these people realize that a positive psychological outlook is critical to long-term survival?”
Sullivan lambasted “the neo-Stalinists who run San Francisco” for their successful campaign against the ads. “Some truly bitter activists in S.F. can’t bear the sight of some people actually doing well on HIV medications, thriving physically, repairing their lives and responding to ads that help keep their spirits up and their minds educated.” He also defended the profit-making premise of the drug company’s ad campaigns. “Why would anyone want to access a drug whose ad implies it will make you look like hell? (Besides, are some difficult side-effects more troublesome than the alternative?)”
But critics of the ads say that the image of HIV they portray is dangerously misleading. What’s more, the amount spent on advertising seems morally outrageous to some. A 1999 study by AIDS Action, a Washington lobby, concluded that drug makers spend close to three times as much on advertising and administration as they do on research and development of all drug lines, $68.5 and $24.5 billion a year respectively.
“The sense that is perpetuated by these advertisements is that AIDS drugs are just another lifestyle medication, like [the antihistamine] Claritin or [anti-balding medications] Rogaine or Propecia,” says Alexis Schuler, government affairs director for AIDS Action. “All these things you see more and more with direct consumer advertising. There’s a large profit to be had, and I can understand why they do it. But they give the perception that you can take a pill and that’s how you manage AIDS. It’s wrong, and it’s not reality. It colors the perception of what it means to be HIV-positive or to have AIDS. It creates the perception that you don’t have to worry about it — AIDS won’t impact your life. Ultimately, that contributes to complacency about safe sex.”
On the front lines of the AIDS fight, some healthcare workers say they have noticed the same dangerous trend. Rick Loftus works in San Francisco General Hospital’s Ward 86, once a place where patients wasting away with AIDS went to die. But Loftus, who’s doing his medical residency through the University of California, has seen how the atmosphere is changing, with many patients responding to treatments and living longer and healthier lives.
Standing before the San Francisco Board of Supervisors at a hearing last month, Loftus shared an anecdote that he believes illustrates the downside of the recent direct-to-consumer pharmaceutical marketing campaigns. A patient told him that one evening after he left the Market Street Gym in San Francisco’s predominantly gay Castro District, a young friend stopped him. He asked the patient (call him “John”) to coffee at a cafe across the street. He told John, a healthy, muscular and HIV-positive man, that he’d been engaging in a lot of unsafe sex lately.
John told Loftus that he thought the young man was merely offering a confessional in the hopes that John would call him on his self-destructive behavior. Instead, the young man told John, “I see a lot of HIV-positive guys at the gym with pot bellies and hollow cheeks, but you look really good.” He then asked John about his HIV medication regiment.
“What are you taking?” he asked. “When I get infected, I’m going to have my doctor put me on the same medications.”
The remark astounded John, who then went on to explain to the young man the reality of taking anti-AIDS medication, like the 18-month bout of diarrhea that followed his first cocktail therapy treatments. “There’s no guarantee that if you take these drugs you won’t develop the pot belly and hollow cheeks that you see on other HIV-positive men,” he told his friend.
It’s anecdotes like Loftus’ that activists are using in their fight against the drug companies. It also raises the question of whether young gay men are abandoning safe sex practices because of the advertising. And beyond that, there’s the whole question of whether direct-to-consumer advertising leads patients to request medications or treatments that they don’t need.
Joel Gallant, an assistant professor of medicine and a prominent AIDS treatment expert at Johns Hopkins University, says a number of his patients in Baltimore have requested the anti-wasting drug Oxandrin. Ads for the drug, a muscle-building anabolic steroid, depict a trio of healthy looking guys, including a muscular clone of actor Antonio Sabato Jr.
“I had a lot of patients coming to me who have no problems with wasting whatsoever, who have been asking for Oxandrin so they can look better at the beach,” Gallant complains. “They’ll say, ‘I want to take it to prevent wasting.’ They say they don’t want to get to that point. The ads are partially to blame for this because they consistently use these gorgeous, buff model guys.”
Though Gallant says he hasn’t had problems with patients requesting anti-retroviral drug brands they have seen in advertisements, he is concerned that they send out the wrong message. “The problem is that they give out a message that HIV is no big deal and that positive guys are cool — they’re buff and pretty. If you get HIV, all you need is to take these medications and you’ll be cool,” he says. “They all want to make their drugs look easy to take. They don’t want the image of some guy puking his guts out in a toilet bowl. Instead, the guy just pops the pill twice a day and lives a healthy life because of the drugs.”
While Gallant believes the advertisements are contributing to an atmosphere of ignorance and ambivalence that is fueling increased HIV infection rates among young gay men, he concedes that it’s difficult to know what to do. “I’m not sure how I feel about regulating the ads,” he says, “but I am worried about the bigger issue of nonchalance emerging in the gay community about HIV.”
AIDS activists in San Francisco, backed by Supervisor Tom Ammiano, have launched a two-pronged effort — one aimed at getting the city to ban the ads, and the other aimed at getting the FDA to take action. The FDA issued its order last month as activists in San Francisco stepped up their efforts.
The director of the FDA’s HIV/AIDS program, Richard Klein, credits San Francisco activist Jeff Getty of Survive AIDS for drawing the agency’s attention to the HIV ads. Though the FDA has been reviewing all direct-to-consumer advertising, it took special note of the HIV drug ads as the controversy stewed. Klein says the FDA reviewed the ads and found that the pharmaceutical companies were “pushing the envelope too far with the models.”
“The FDA’s move came sooner than we expected, and it was exactly what we asked for,” says Getty, a longtime activist whose organization formed out of the wreckage of SF ACT-UP. “They’re saying you can’t pictorially mislead the consumer, and they’ve never done this before.” For months now, Getty has been leading the campaign against the pharmaceutical giants, dubbing the advertisements the “Joe Camel ads of AIDS.” “They misrepresent the way people with HIV and AIDS often look.”
He points to an ad for the drug Zerit, which includes a scantily clad man and a line claiming he takes the drug because his friends do. “That’s bad advertising,” says Getty. “You don’t take drugs because you friends take drugs unless it’s ecstasy.” The advertisements, Getty says, promote HIV as something glamorous. “It’s like, ‘Come join Club HIV!’”
Forty-three-year-old Getty has had HIV most of his adult life. He became infected with the virus when he was 23, and made treatment history in 1996 when he lobbied the FDA to permit him to have a bone marrow transplant from a baboon. The procedure was ultimately ineffective. “I felt good for about a year,” he says, but his condition worsened and his body hasn’t responded to the cocktail treatments. “Now I’m very sick,” he says.
Given their surprise victory in the advertising battle, Getty says he and other activists in the city are adopting a wait-and-see approach. “The city will look at the new ads. If it turns out the ads are unacceptable, we’ll drop” the campaign, he says.
Daryl Lindsey is associate editor of Salon News and an Arthur Burns fellow. He currently lives in Berlin and writes for Salon and Die Welt. More Daryl Lindsey.
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